Personalized medicine
in your pocket

A small set of so-called pharmacogenes has an impact on the safety and efficacy of many common medications. The Medication Safety Code makes data about these these pharmacogenes available whenever needed during medical care.

The availability of pharmacogenomic data of individual patients can significantly improve physicians' prescribing behaviour and lead to a reduced incidence of adverse drug events and an improvement of effectiveness of treatment. Unfortunately, major barriers to the wide-spread implementation of pharmacogenomics in clinical practice remain:

Significant financial cost and turnaround time as well as limited availability of indication-specific pharmacogenomic tests.

Difficulties in the storage, exchange, and interpretation of pharmacogenetic data. In particular, interoperable electronic health record systems that are capable of storing structured genetic test results and transmitting those results to other care providers are needed; unfortunately, this type of infrastructure is not available in most parts of the world.

A lack of easily accessible computer-based clinical decision support systems that can assist clinicians with the interpretation of pharmacogenetic data – a vital component to the use of these data at the point of care.

A possible solution: the Medicine Safety Code

To make patient genotype data on essential pharmacogenes globally available for routine medical care, technologically-simple and intuitive systems are required in order to minimize the need for specialized infrastructure, software, and knowledge. The Medication Safety Code initiative is an effort to improve the ability of clinicians and patients to share pharmacogenetic data and to use it at the point of care. This system consists of two major components:

The Medication Safety Code (MSC), a standardized two-dimensional (2D) barcode that captures data about genetic variants in essential pharmacogenes for an individual patient. The 2D barcode is based on the Quick Response (QR) code standard, which has become widely popular in recent years because it can be decoded quickly and reliably, has relatively high information density and can encode hyperlinks to pages on the World Wide Web. In addition, the MSC data can also be embedded in electronic health records.

A curated knowledge base that contains information about essential pharmacogenes, including haplotype definitions, phenotype translations and clinical guidelines. This knowledge base is used to automatically interpret the genetic data that is encoded within the 2D barcodes. The knowledge base leverages semantic technologies and ontologies to ensure a high degree of interoperability with other systems.

A proof-of-concept prototype of the MSC system has been developed and performed well in preliminary tests. For the prototype, data on 385 pharmacogenetic markers were encoded as a 2D barcode, which could quickly be decoded and interpreted using standard smartphone devices.

Benefits and applications of the Medication Safety Code

The MSC could act as an enabling technology for the widespread dissemination and clinical implementation of pharmacogenetic data and decision support for several reasons:

Immediately implementable. The MSC is based on technology that is low-cost and widely available, and implementations would require minimal integration with existing clinical infrastructure.

No specialized hardware or software is required to use the codes. The 2D barcodes used by the MSC can be printed on personalized cards that patients can carry in their wallets, or they can be incorporated in paper-based lab reports. The images can also be saved electronically and shared via e-mail. The 2D barcodes can be quickly decoded using common smartphone devices to yield clinical decision support messages that are pertinent to the individual's genetic profile.

Providing access to decision support, anywhere. The MSC enables patients and care providers to access pharmacogenomic data and relevant clinical decision support algorithms in all health care settings, including outpatient and emergency situations, regardless of whether the care facility has implemented a genome-enabled electronic medical record and local clinical decision support algorithms.

Patients can opt-in and opt-out at any time. Patients can choose whether or not to carry their anonymized pharmacogenomic data in their pockets and make their data available to care providers.

Independent of the genotyping platform. The MSC captures the result of genetic testing independently from the platform that was used to produce the results. Therefore, a wide variety of genotyping or sequencing platforms can be used to generate standardized representations of the most important test results on essential pharmacogenes.

Local implementations can be deployed. The MSC system aims to be independent from local technological platforms, since no specialized equipment is needed for creating, transporting and interpreting the pharmacogenetic information. No investment in a dedicated infrastructure is required to start using the system, but if a customized implementation is desired, the MSC can be deployed locally. The system specifications and source code will be made openly available.

Lowering costs through data re-use. The MSC provides a simple, effective means for sharing genetic test results at the point of care. Costs for pharmacogenetic testing could be reduced by facilitating the re-use of genetic test results and a reduction in redundant testing.

Barcodes are customizable. Custom 2D barcodes can be created for specific gene panels, if needed.

Facilitating return of results. The MSC could be used as a simple, low-cost method for returning genetic test results to patients.

Facilitating the development of tailored therapeutics. Last but not least, a broad adoption of the MSC could also provide benefits for drug development. When data on a minimal set of essential pharmacogenes are made cheaply available for large patient populations, these pharmacogenes could be used for patient stratification during clinical trials (‘tailored therapeutics’). This could help to bring new therapies to market faster and with fewer losses caused by concerns about safety and efficacy, which are often encountered in the development of non-tailored therapeutics.

The MSC is intended to complement local pharmacogenomics initiatives by providing a simple method for making pharmacogenetic data more portable across geographic regions and health care networks.

Join to make ubiquitous personalized medicine a reality!

The MSC is a technologically-simple and intuitive system that could address many of the barriers that limit the ability to share and utilize pharmacogenetic test results in clinical practice, but the true potential of this project will not be realized until the MSC is tested in different scenarios. Partnerships with clinical institutions, researchers, pharmaceutical companies, genetic testing providers, health IT companies and governmental organizations are needed.

To start participating in the Medication Safety Code initiative, or to be kept up-to-date with new developments, please join the (low-traffic) Google Group / mailing list of the initiative: